TARRYTOWN, N.Y. and
PARIS, May
22, 2020 /PRNewswire/ --
Dupixent demonstrated significant clinical and anatomic
improvements, including the ability to swallow, in Part A of
pivotal trial
69% reduction in disease symptoms with Dupixent, compared to
32% for placebo (p=0.0002)
There are currently no FDA-approved treatments for
eosinophilic esophagitis, a condition that impacts patients'
ability to eat
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced positive results from Part A of the pivotal Phase 3 trial
evaluating Dupixent® (dupilumab) in patients 12 years
and older with eosinophilic esophagitis (EoE). The trial met both
of its co-primary endpoints, as well as all key secondary
endpoints. Dupixent is the first and only biologic to show positive
and clinically-meaningful results in this population as part of a
Phase 3 trial. An ongoing Part B portion of the Phase 3 trial
evaluates an additional Dupixent dosing regimen.
EoE is a chronic and progressive type 2 inflammatory disease
that damages the esophagus and prevents it from working properly,
leading to difficulties in swallowing. If untreated, symptoms and
inflammation can progress, causing functional damage and scarring
of the esophagus. EoE can lead to esophageal food impaction,
requiring immediate emergency room visits. Almost half of the
patients in this trial had prior procedures such as dilation of
their esophagus, and almost three-quarters had previously been
treated with corticosteroids. In the U.S., there are approximately
160,000 patients with EoE who are currently treated, of which
approximately 50,000 have failed multiple treatments. There are
currently no therapies approved by the U.S. Food and Drug
Administration (FDA).
"Eosinophilic esophagitis can be debilitating, and there are no
approved treatment options. It impacts patients' ability to eat,
causes severe pain and often results in repeated emergency room
visits and medical procedures," said George
D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief
Scientific Officer of Regeneron. "These data are particularly
impressive, as Dupixent not only dramatically reduced eosinophils
in the esophagus, but also improved all clinical, anatomic and
histologic measures of the disease. In the past, EoE was thought to
be a disease caused by eosinophils, but other biologics that
decrease eosinophils in the esophagus did not demonstrate
consistent clinical or anatomical improvements. These Dupixent
results demonstrate EoE is caused by multiple aspects of type 2
inflammation, driven by interleukin-4 and interleukin-13.
EoE is the fourth atopic or type 2 inflammatory disease in
which Dupixent has pivotal data demonstrating significant
efficacy."
"These data demonstrate Dupixent's potential to continue to
address treatment gaps across the spectrum of type 2
inflammatory diseases as common as asthma and as rare as
eosinophilic esophagitis," said John
Reed, M.D., Ph.D., Global Head of Research and Development
at Sanofi. "For the first time in a Phase 3 trial, patients
reported an improvement in their ability to swallow food. For
patients with eosinophilic esophagitis who are living with
restricted diets and, in some cases, repeated hospital
interventions, these findings are encouraging."
Part A of the trial enrolled 81 patients (42 with Dupixent, 39
with placebo) aged 12 years and older with EoE, as determined by
histological and patient-reported measures. The co-primary
endpoints assessed the change from baseline in the Dysphagia
Symptom Questionnaire (DSQ), a patient-reported measure of
difficulty swallowing, and the proportion of patients achieving
peak esophageal intraepithelial eosinophil count of ≤6 eos/hpf, a
measure of esophageal inflammation, at 24 weeks.
Patients treated with Dupixent 300 mg weekly experienced the
following changes by week 24 from baseline:
- 69% reduction in disease symptoms compared to 32% for placebo
(p=0.0002). Disease symptoms were measured by the DSQ scale, where
patients experienced a 21.92 point improvement with Dupixent
compared to a 9.60 point improvement for placebo, on a 0-84 scale
(p=0.0004), the co-primary endpoint; baseline DSQ scores were
approximately 34 points.
- 60% reduction in their esophageal eosinophilic count to a
normal range compared to 5% for placebo (p<0.0001), the
co-primary endpoint. This was measured by the proportion of
patients who achieved a peak esophageal intraepithelial eosinophil
count of ≤6 eos/hpf (a normal range); mean baseline peak levels
were 89 eos/hpf.
- 39% reduction in abnormal endoscopic findings compared to 0.6%
for placebo. This was measured by the EoE Endoscopic Reference
Score (EoE-EREFS), where patients experienced a 3.2 point reduction
with Dupixent compared to a 0.3 point reduction for placebo
(p<0.0001).
The trial demonstrated similar safety results to the known
safety profile of Dupixent in its approved indications. For the
24-week treatment period, overall rates of adverse events were
86% for Dupixent and 82% for placebo. Adverse events that were
more commonly observed with Dupixent included injection site
reactions (n=15 for Dupixent and n=12 for placebo) and upper
respiratory-tract infections (n=11 for Dupixent and n=6 for
placebo). There was one treatment discontinuation in the Dupixent
group due to arthralgia.
Detailed results from this trial will be presented at an
upcoming medical meeting. Dupixent received Orphan Drug Designation
from the FDA in 2017 for the potential treatment of EoE. This
status is given to investigational medicines intended for the safe
and effective treatment of rare diseases that affect fewer than
200,000 people in the U.S. The potential use of Dupixent in
eosinophilic esophagitis is currently under clinical development,
and the safety and efficacy have not been fully evaluated by any
regulatory authority.
Dupixent is a fully-human monoclonal antibody that inhibits the
signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13)
proteins. Data from Dupixent clinical trials have shown that IL-4
and IL-13 are key drivers of the type 2 inflammation that plays a
major role in atopic dermatitis, asthma, chronic rhinosinusitis
with nasal polyposis and eosinophilic esophagitis.
About the Dupixent Eosinophilic Esophagitis Trial
The
Phase 3, randomized, double-blind, placebo-controlled trial
evaluated the efficacy and safety of Dupixent in adolescents and
adults with eosinophilic esophagitis. Part A of the trial enrolled
81 patients aged 12 years and older with eosinophilic esophagitis,
as determined by histological and patient-reported measures. In
total, 85% of these patients suffered from at least one concurrent
atopic condition such as allergic rhinitis, food allergy and
asthma. Patients received weekly subcutaneous injections of
Dupixent 300 mg or placebo for the 24-week treatment period.
The trial is ongoing, with additional patients enrolling in Part
B as well as patients continuing in a 28-week extended active
treatment period (Part C).
Dupilumab Development Program
In addition to the
currently approved indications, Regeneron and Sanofi are also
studying dupilumab in a broad range of clinical development
programs for diseases driven by allergic and other type 2
inflammation, including pediatric asthma (6 to 11 years of age,
Phase 3), pediatric atopic dermatitis (6 months to 5 years of age,
Phase 2/3), chronic obstructive pulmonary disease (Phase 3),
bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic
spontaneous urticaria (Phase 3), and food and environmental
allergies (Phase 2). These potential uses are investigational, and
the safety and efficacy have not been evaluated by any regulatory
authority. Dupilumab is being jointly developed by Regeneron and
Sanofi under a global collaboration agreement.
Dupilumab was invented using Regeneron's proprietary
VelocImmune® technology that utilizes a
proprietary genetically-engineered mouse platform endowed with a
genetically-humanized immune system to produce optimized
fully-human antibodies. VelocImmune technology has been
used to create multiple antibodies including Libtayo®
(cemiplimab-rwlc), Praluent® (alirocumab) and
Kevzara® (sarilumab), which are approved in multiple
countries around the world. Regeneron previously used these
technologies to rapidly develop a treatment for Ebola virus
infection, which is currently under review by the FDA, and is now
being used in efforts to create prophylactic and treatment
medicines for COVID-19.
U.S. Indications
DUPIXENT is a prescription medicine used:
- to treat people 12 years of age and older with
moderate-to-severe atopic dermatitis (eczema) that is not well
controlled with prescription therapies used on the skin (topical),
or who cannot use topical therapies. DUPIXENT can be used with or
without topical corticosteroids. It is not known if DUPIXENT is
safe and effective in children with atopic dermatitis under 12
years of age.
- with other asthma medicines for the maintenance treatment of
moderate-to-severe eosinophilic or oral steroid dependent asthma in
people aged 12 years and older whose asthma is not controlled with
their current asthma medicines. DUPIXENT helps prevent severe
asthma attacks (exacerbations) and can improve your breathing.
DUPIXENT may also help reduce the amount of oral corticosteroids
you need while preventing severe asthma attacks and improving your
breathing. DUPIXENT is not used to treat sudden breathing problems.
It is not known if DUPIXENT is safe and effective in children with
asthma under 12 years of age.
- with other medicines to treat chronic rhinosinusitis with nasal
polyposis in adults whose disease is not controlled. It is not
known if DUPIXENT is safe and effective in children with chronic
rhinosinusitis with nasal polyposis under 18 years of age.
IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS
Do not use if you are allergic to dupilumab or to any of
the ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider about
all your medical conditions, including if you:
- have eye problems.
- have a parasitic (helminth) infection.
- are taking oral, topical, or inhaled corticosteroid medicines.
Do not stop taking your corticosteroid medicines unless instructed
by your healthcare provider. This may cause other symptoms that
were controlled by the corticosteroid medicine to come back.
- are scheduled to receive any vaccinations. You should not
receive a "live vaccine" if you are treated with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known
whether DUPIXENT will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known
whether DUPIXENT passes into your breast milk.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins and
herbal supplements. If you are taking asthma medicines, do not
change or stop your asthma medicine without talking to your
healthcare provider.
DUPIXENT can cause serious side effects, including:
- Allergic reactions (hypersensitivity), including a severe
reaction known as anaphylaxis. Stop using DUPIXENT and tell
your healthcare provider or get emergency help right away if you
get any of the following symptoms: breathing problems, fever,
general ill feeling, swollen lymph nodes, swelling of the face,
mouth and tongue, hives, itching, fainting, dizziness, feeling
lightheaded (low blood pressure), joint pain, or skin rash.
- Eye problems. Tell your healthcare provider if you have
any new or worsening eye problems, including eye pain or changes in
vision.
- Inflammation of your blood vessels. Rarely, this can
happen in people with asthma who receive DUPIXENT. This may happen
in people who also take a steroid medicine by mouth that is being
stopped or the dose is being lowered. It is not known whether this
is caused by DUPIXENT. Tell your healthcare provider right away if
you have: rash, shortness of breath, persistent fever, chest pain,
or a feeling of pins and needles or numbness of your arms or
legs.
The most common side effects include:
- Atopic dermatitis: injection site reactions, eye and
eyelid inflammation, including redness, swelling, and itching, and
cold sores in your mouth or on your lips.
- Asthma: injection site reactions, pain in the throat
(oropharyngeal pain), and high count of a certain white blood cell
(eosinophilia).
- Chronic rhinosinusitis with nasal polyposis: injection
site reactions, eye and eyelid inflammation, including redness,
swelling, and itching, high count of a certain white blood cell
(eosinophilia), trouble sleeping (insomnia), toothache, gastritis,
and joint pain (arthralgia).
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away. These are not all the
possible side effects of DUPIXENT. Call your doctor for medical
advice about side effects. You are encouraged to report negative
side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed. DUPIXENT is an injection
given under the skin (subcutaneous injection). If your healthcare
provider decides that you or a caregiver can give DUPIXENT
injections, you or your caregiver should receive training on the
right way to prepare and inject DUPIXENT. Do not try to inject
DUPIXENT until you have been shown the right way by your healthcare
provider. In children 12 years of age and older, it is recommended
that DUPIXENT be administered by or under supervision of an adult.
Please see full Prescribing Information including
Patient Information.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that
invents life-transforming medicines for people with serious
diseases. Founded and led for over 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to seven
FDA-approved treatments and numerous product candidates in
development, all of which were homegrown in our laboratories. Our
medicines and pipeline are designed to help patients with eye
diseases, allergic and inflammatory diseases, cancer,
cardiovascular and metabolic diseases, pain, infectious diseases
and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune®, which uses unique
genetically-humanized mice to produce optimized fully-human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100
countries, Sanofi is transforming scientific innovation
into healthcare solutions around the globe.
Sanofi, Empowering Life
Regeneron Forward-Looking Statements and Use of Digital
Media
This press release includes forward-looking statements that
involve risks and uncertainties relating to future events and the
future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron"
or the "Company"), and actual events or results may differ
materially from these forward-looking statements. Words such as
"anticipate," "expect," "intend," "plan," "believe," "seek,"
"estimate," variations of such words, and similar expressions are
intended to identify such forward-looking statements, although not
all forward-looking statements contain these identifying
words. These statements concern, and these risks and
uncertainties include, among others, the impact of SARS-CoV-2 (the
virus that has caused the COVID-19 pandemic) on Regeneron's
business and its employees, collaborators, suppliers, and other
third parties on which Regeneron relies, Regeneron's and its
collaborators' ability to continue to conduct research and clinical
programs, Regeneron's ability to manage its supply chain, net
product sales of products marketed by Regeneron and/or its
collaborators (collectively, "Regeneron's Products"), and the
global economy; the nature, timing, and possible success and
therapeutic applications of Regeneron's Products and Regeneron's
product candidates and research and clinical programs now underway
or planned, including without limitation Dupixent®
(dupilumab) in patients 12 years and older with eosinophilic
esophagitis; uncertainty of market acceptance and commercial
success of Regeneron's Products and product candidates and the
impact of studies (whether conducted by Regeneron or others and
whether mandated or voluntary) on the commercial success of
Regeneron's Products and product candidates; the likelihood,
timing, and scope of possible regulatory approval and commercial
launch of Regeneron's product candidates and new indications for
Regeneron's Products, such as dupilumab for the treatment of
eosinophilic esophagitis, pediatric asthma, pediatric atopic
dermatitis, chronic obstructive pulmonary disease, bullous
pemphigoid, prurigo nodularis, chronic spontaneous urticaria, food
and environmental allergies, and other potential
indications; unforeseen safety issues resulting from the
administration of Regeneron's Products (such as Dupixent) and
product candidates in patients, including serious complications or
side effects in connection with the use of Regeneron's Products and
product candidates in clinical trials; determinations by regulatory
and administrative governmental authorities which may delay or
restrict Regeneron's ability to continue to develop or
commercialize Regeneron's Products and product candidates; ongoing
regulatory obligations and oversight impacting Regeneron's
Products, research and clinical programs, and business, including
those relating to patient privacy; the availability and extent of
reimbursement of Regeneron's Products (such as Dupixent) from
third-party payers, including private payer healthcare and
insurance programs, health maintenance organizations, pharmacy
benefit management companies, and government programs such as
Medicare and Medicaid; coverage and reimbursement determinations by
such payers and new policies and procedures adopted by such payers;
competing drugs and product candidates that may be superior to
Regeneron's Products and product candidates; the extent to which
the results from the research and development programs conducted by
Regeneron and/or its collaborators may lead to advancement
of product candidates to clinical trials or therapeutic
applications; the ability of Regeneron to manufacture and manage
supply chains for multiple products and product candidates; the
ability of Regeneron's collaborators, suppliers, or other third
parties (as applicable) to perform manufacturing, filling,
finishing, packaging, labeling, distribution, and other steps
related to Regeneron's Products and product candidates;
unanticipated expenses; the costs of developing, producing, and
selling products; the ability of Regeneron to meet any of its
financial projections or guidance and changes to the assumptions
underlying those projections or guidance; the potential for any
license or collaboration agreement, including Regeneron's
agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries
Ltd. (or their respective affiliated companies, as applicable), to
be cancelled or terminated without any further product success; and
risks associated with intellectual property of other parties and
pending or future litigation relating thereto (including without
limitation the patent litigation and other related proceedings
relating to Dupixent and Praluent® (alirocumab)),
other litigation and other proceedings and government
investigations relating to the Company and/or its operations, the
ultimate outcome of any such proceedings and investigations, and
the impact any of the foregoing may have on Regeneron's business,
prospects, operating results, and financial condition. A more
complete description of these and other material risks can be found
in Regeneron's filings with the U.S. Securities and Exchange
Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the
quarterly period ended March 31,
2020. Any forward-looking statements are made based on
management's current beliefs and judgment, and the reader is
cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to update
publicly any forward-looking statement, including without
limitation any financial projection or guidance, whether as a
result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
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Twitter feed (http://twitter.com/regeneron).
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include projections and
estimates regarding the marketing and other potential of the
product, or regarding potential future revenues from the product.
Forward-looking statements are generally identified by the words
"expects", "anticipates", "believes", "intends", "estimates",
"plans" and similar expressions. Although Sanofi's management
believes that the expectations reflected in such forward-looking
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generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the fact that product may not
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and development, including future clinical data and analysis of
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and any related future litigation and the ultimate outcome of such
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impact that COVID-19 will have on us, our customers, suppliers,
vendors, and other business partners, and the financial condition
of any one of them, as well as on our employees and on the global
economy as a whole. Any material effect of COVID-19 on any of
the foregoing could also adversely impact us. This situation is
changing rapidly and additional impacts may arise of which we are
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Regeneron
Contacts:
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Media
Relations
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Investor
Relations
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Sharon
Chen
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Mark
Hudson
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Tel: + (914)
847-1546
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Tel: +1 (914)
847-3482
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Sharon.Chen@regeneron.com
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Mark.Hudson@regeneron.com
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Sanofi
Contacts:
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Media
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Investor
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Tel.: +1 (732)
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Tel: +33 (0)1 53 77
45 45
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Nicolas.Kressmann@sanofi.com
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ir@sanofi.com
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SOURCE Regeneron Pharmaceuticals, Inc.